Cleared Traditional

K971946 - NPB-190 PULSE OXIMETER (NPB-190)

K971946 is an FDA 510(k) clearance for NPB-190 PULSE OXIMETER (NPB-190), manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971946 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971946 is an FDA 510(k) clearance for the NPB-190 PULSE OXIMETER (NPB-190). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Lenexa, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K971946

510(k) Number K971946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date August 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K971946.
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
K970061 · Datascope Corp. · Sep 1997
NPB-195 PULSE OXIMETER
K972468 · Nellcor Puritan Bennett, Inc. · Sep 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · Siemens Medical Solutions USA, Inc. · Sep 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · Alexander Mfg. Co. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · Alexander Mfg. Co. · Aug 1997
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · Medical Data Electronics · Jul 1997